US6258019B1 - Catheter for intraluminal treatment of a vessel segment with ionizing radiation - Google Patents
Catheter for intraluminal treatment of a vessel segment with ionizing radiation Download PDFInfo
- Publication number
- US6258019B1 US6258019B1 US09/391,433 US39143399A US6258019B1 US 6258019 B1 US6258019 B1 US 6258019B1 US 39143399 A US39143399 A US 39143399A US 6258019 B1 US6258019 B1 US 6258019B1
- Authority
- US
- United States
- Prior art keywords
- balloon
- catheter
- shaft
- inflation lumen
- ionizing radiation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1002—Intraluminal radiation therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M2025/0183—Rapid exchange or monorail catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1072—Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1002—Intraluminal radiation therapy
- A61N2005/1003—Intraluminal radiation therapy having means for centering a radioactive source within the lumen, e.g. balloons
Definitions
- the invention relates to prepared catheters for intraluminal treatment of a vessel section with ionizing radiation.
- the invention relates to prepared balloon catheters for such use.
- Catheters for intraluminal treatment of a vessel section with ionizing radiation are used, for example, during or after percutaneous transluminal angioplasty, such as balloon dilatation or atherectomy of a stenosed blood vessel section, in order to prevent restenosis of this section.
- percutaneous transluminal angioplasty such as balloon dilatation or atherectomy of a stenosed blood vessel section
- a catheter of the generic type can also be used for radiation treatment of other body cavities such as the esophagus or trachea or for treatment of the prostate.
- a balloon catheter of the type mentioned in the introduction is known from EP 633,041 A1, in which a guide wire is arranged to be longitudinally displaceable in a central guide wire lumen of a two-lumen balloon catheter.
- An emitter of radioactive radiation in the form of a filament is incorporated into the tip of the guide wire.
- the second lumen serves as an inflation lumen for the balloon.
- Inflation of the balloon serves to radially center the radiation emitter positioned in the guide wire lumen in the vessel section that is to be treated. In this way, a radiation dose distribution is obtained uniformly about the circumference of the vessel wall.
- a conventional liquid solution is used for applying the pressure to the balloon.
- the radiation source preferably used is yttrium-90, an easily screenable beta emitter with a half-life of 2.7 days, a mean electron energy of 0.942 MeV and a maximum electron energy of 2.28 MeV.
- the radioactive radiation has to pass through inflation medium, in which process—as in any matter—radiation energy is absorbed.
- the energy dose available at the surface of the vessel wall, and the depth of penetration of the radiation into the vascular tissue at the wall depend on the initial activity of the source, on the coefficient of absorption of the inflation medium, and on the length of travel of the radiation through the inflation medium.
- the conventional liquid solution used to inflate the balloon includes saline and radiopaque contrast media which have a significant coefficient of absorption.
- known catheters of the type mentioned in the introduction suffer the drawback of long irradiation times, and consequently, long treatment times. Because of the necessary centering of the emitter in an inflated balloon, the flow of blood in the treated vessel has to be interrupted during this long treatment, which is undesirable.
- the invention is therefore based on the object of providing a balloon catheter, in which as small a proportion as possible of the ionizing radiation is absorbed on its travel from the source through the inflated balloon to the vessel section that is to be treated. It is also based on the object of providing a balloon catheter which has short deflation times and has a small overall profile.
- the object is achieved by means of a balloon catheter inflated with a gas, as opposed to a conventional liquid.
- the inflation medium is a gas
- the radiation passes through a medium with a comparatively low coefficient of absorption, since the latter is generally higher for liquids than it is for gases. Therefore, the radiation attenuates only slightly as it passes through the inflation medium, so that a sufficient radiation dose can be delivered to the vessel section within a short time.
- the radiation intensity is less dependent on the source distance, as a result of which inaccuracies in the centering of the source have only slight effects on the uniformity of the dose distribution.
- gas-filled balloons have up to about three times shorter deflation times compared to balloons which have been inflated with liquid, a fact which is attributable to the lower viscosity of gases compared to liquids.
- the advantage of this is, for example, that when providing treatment using a balloon which interrupts the flow of blood, it is possible to respond quickly to an ischaemic reaction on the part of the patient by deflating the balloon.
- the inflation medium used is a gas (i.e., a lower viscosity than the conventional inflation liquid media)
- the inflation lumen it is possible, while having essentially the same deflation time, for the inflation lumen to be made smaller in cross-section along the greater part of its length running within the patient during treatment, with greater advantages for all other properties of the catheter.
- the flow of contrast medium is improved, while at the same time, however, the flexibility and the kink resistance are also improved, since with smaller shaft diameters the wall thickness can be reduced.
- the reduction in cross-section which can be achieved by means of the invention can either be specified in absolute values, as specified in the claims, or, as specified in other claims, as a function of the maximum use volume of the balloon which has to be deflated.
- the inflation medium is carbon dioxide.
- the blood In the treatment of blood vessels, it is possible, in the event of a leaking or defective balloon, for the blood to absorb a certain amount of carbon dioxide without harming the patient. Since carbon dioxide is transported anyway in the blood, its biological tolerability in humans is not in question.
- the inflation lumen has, along the greater part of its length lying within the patient's body during treatment, a cross-sectional area of at most 0.300 mm 2 , or at most 0.200 mm 2 .
- the cross-sectional area of the inflation lumen can also be defined as a function of the balloon volume, for example when expressed in mm 2 , not greater than a maximum use volume of the balloon in mm 3 divided by 1200 or 1600.
- the present invention relates to a catheter for intraluminal treatment of a vessel section, which catheter has an elongate shaft with a proximal end and a distal end, a balloon which is arranged at the distal end of the shaft and can be inflated to a maximum use volume, and an inflation lumen which runs through the shaft and opens into the balloon, and which catheter is filled with an inflation medium for applying pressure to the balloon.
- the inflation medium has a viscosity which is lower than that of water.
- the inflation lumen may have along the greater part of the length lying within the patient's body during treatment a cross-sectional area having a value in mm 2 not greater than the maximum use volume of the balloon in mm 3 divided by 1200, optionally not greater than the maximum use volume of the balloon in mm 3 divided by 1600.
- the inflation lumen may have along the greater part of the length lying within the patient's body during treatment a cross-sectional area of at most 0.300 mm 2 , optionally at most 0.200 mm 2 .
- the inflation medium may be a gas, preferably carbon dioxide.
- FIG. 1 shows, in a longitudinal cutaway, the distal section of a catheter according to the invention.
- a catheter according to the invention for intraluminal treatment of a vessel section with ionizing radiation has a three-lumen shaft 1 which has a proximal end (not shown) and a distal end 2 , and serves as transluminal access to the vessel section.
- the shaft 1 is made up of an outer shaft 1 b and an inner shaft 1 a which runs coaxially inside the latter and projects distally from it.
- a tip 3 of the inner shaft 1 b there is a short guide wire lumen 4 for receiving a guide wire (not shown, course indicated by dot-and-dash line 5 ), onto which the catheter is threaded in order to be advanced through the vessel system.
- a central lumen 6 which is closed distally is used for receiving a stiffening wire (not shown) which transmits axial thrust to the tip 3 as the shaft 1 is being advanced.
- An annular inflation lumen 7 running between inner shaft 1 a and outer shaft 1 b opens into a balloon 8 arranged at the distal end 2 of the shaft 1 , which balloon 8 is filled, via the inflation lumen 7 , with an inflation medium 9 , for example carbon dioxide, and is thereby inflated.
- an inflation medium 9 for example carbon dioxide
- the use of carbon dioxide as inflation medium permits a reduction in the cross-sectional area of the inflation lumen 8 , for example to values of less than 0.300 mm 2 , although cross-sectional areas of less than 0.200 mm 2 have already been produced.
- the achievable ratio between the maximum use volume of the balloon and the cross-sectional area of the inflation lumen, with tolerable emptying times, is approximately 1200:1.
- the emptying times evolving from a ratio of 1600:1 have also been accepted in some cases.
- the inflated balloon 8 is subdivided into a plurality of balloon segments by constrictions which are formed by ring elements 10 , as a result of which the central lumen 6 is radially centered even in the event of deformation of the inner shaft 1 a .
- the stiffening wire is removed from the central lumen 6 and replaced by a source wire 11 into which a source 12 of ionizing radiation is incorporated distally.
- the source 12 is, for example, a filament of yttrium-90, which is positioned in the balloon is such a way that the emitted beta radiation substantially passes through the inflation medium 9 on its travel to the vessel wall.
- the carbon dioxide used as inflation medium is, for example, kept ready in gas bottles at a pressure of 11 bar, for example.
- the gas pressure can be reduced via a reducing valve, so that an inflation syringe can also be filled with carbon dioxide in the sterile area of a catheter laboratory.
- Air is removed from the balloon and inflation lumen of the catheter in a customary manner, for instance with a syringe creating a vacuum.
- the balloon can thereafter be inflated with the carbon dioxide taken up by the inflation syringe.
Abstract
Description
Claims (7)
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP97202957A EP0904798B1 (en) | 1997-09-26 | 1997-09-26 | Carbon dioxide inflated radio-therapy balloon catheter |
EP97202957 | 1997-09-26 | ||
EP97202958A EP0904799A1 (en) | 1997-09-26 | 1997-09-26 | Dilation catheter with balloon having a determined ration of balloon volume and square surface of the inflation lumen |
EP97202958 | 1997-09-26 | ||
US3423898A | 1998-03-04 | 1998-03-04 | |
US3424598A | 1998-03-04 | 1998-03-04 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US3423898A Continuation-In-Part | 1997-09-26 | 1998-03-04 |
Publications (1)
Publication Number | Publication Date |
---|---|
US6258019B1 true US6258019B1 (en) | 2001-07-10 |
Family
ID=27443524
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/391,433 Expired - Lifetime US6258019B1 (en) | 1997-09-26 | 1999-09-08 | Catheter for intraluminal treatment of a vessel segment with ionizing radiation |
Country Status (7)
Country | Link |
---|---|
US (1) | US6258019B1 (en) |
EP (1) | EP0904798B1 (en) |
JP (2) | JPH11114077A (en) |
AT (1) | ATE227145T1 (en) |
AU (1) | AU7183598A (en) |
CA (1) | CA2242996C (en) |
DE (1) | DE59708672D1 (en) |
Cited By (30)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6398709B1 (en) | 1999-10-19 | 2002-06-04 | Scimed Life Systems, Inc. | Elongated member for intravascular delivery of radiation |
US6416492B1 (en) | 2000-09-28 | 2002-07-09 | Scimed Life Systems, Inc. | Radiation delivery system utilizing intravascular ultrasound |
US6416457B1 (en) | 2000-03-09 | 2002-07-09 | Scimed Life Systems, Inc. | System and method for intravascular ionizing tandem radiation therapy |
US20020115902A1 (en) * | 2001-02-22 | 2002-08-22 | Dejuan Eugene | Beta radiotherapy emitting surgical device and methods of use thereof |
US6471671B1 (en) | 2000-08-23 | 2002-10-29 | Scimed Life Systems, Inc. | Preloaded gas inflation device for balloon catheter |
US6514191B1 (en) | 1993-07-01 | 2003-02-04 | Schneider (Europe) A.G. | Medical appliances for the treatment of blood vessels by means of ionizing radiation |
US6582352B2 (en) | 1994-06-10 | 2003-06-24 | Schneider (Europe) A.G. | Medical appliance for treatment by ionizing radiation |
US6582353B1 (en) | 1996-02-29 | 2003-06-24 | Scimed Life Systems, Inc. | Intravascular radiation delivery system |
US6616629B1 (en) | 1994-06-24 | 2003-09-09 | Schneider (Europe) A.G. | Medical appliance with centering balloon |
US20050137621A1 (en) * | 2002-04-08 | 2005-06-23 | Acrostak Corporation | PTCA and/or PTA balloon |
EP1568397A1 (en) * | 2004-02-25 | 2005-08-31 | Acrostak Corp. | Balloon for brachytherapy and application of the balloon |
US20060111605A1 (en) * | 2004-02-12 | 2006-05-25 | Larsen Charles E | Methods and apparatus for intraocular brachytherapy |
US20060129093A1 (en) * | 2004-12-03 | 2006-06-15 | Scimed Life Systems, Inc. | Multiple balloon catheter |
US20060224034A1 (en) * | 2005-04-05 | 2006-10-05 | Kenneth Reever | Radiation shield |
US7182725B2 (en) | 2001-09-24 | 2007-02-27 | Best Vascular, Inc. | Methods and apparatus employing ionizing radiation for treatment of cardiac arrhythmia |
US20070055089A1 (en) * | 2004-02-12 | 2007-03-08 | Larsen Charles E | Methods and apparatus for intraocular brachytherapy |
US20080249461A1 (en) * | 2007-04-04 | 2008-10-09 | Foreman Philip C | Sequentially inflatable balloons for delivery of treatment agents |
US7803103B2 (en) | 2005-02-11 | 2010-09-28 | Neovista Inc. | Methods and apparatus for intraocular brachytherapy |
US20110021986A1 (en) * | 2008-03-07 | 2011-01-27 | Zamboni Paolo | Dilation catheter |
US8353812B2 (en) | 2008-06-04 | 2013-01-15 | Neovista, Inc. | Handheld radiation delivery system |
US9358042B2 (en) | 2013-03-13 | 2016-06-07 | The Spectranetics Corporation | Expandable member for perforation occlusion |
US9402983B1 (en) * | 2012-10-31 | 2016-08-02 | Sainath Intellectual Properties, Llc | Variably expanding balloon catheter |
EP3269415A1 (en) * | 2016-07-11 | 2018-01-17 | Cook Medical Technologies LLC | Multi-stage balloon catheter, and method of operating same in a curved passageway |
US10449336B2 (en) | 2015-08-11 | 2019-10-22 | The Spectranetics Corporation | Temporary occlusions balloon devices and methods for preventing blood flow through a vascular perforation |
US10499892B2 (en) | 2015-08-11 | 2019-12-10 | The Spectranetics Corporation | Temporary occlusion balloon devices and methods for preventing blood flow through a vascular perforation |
US20200164187A1 (en) * | 2004-04-21 | 2020-05-28 | Acclarent, Inc. | Devices, systems and methods useable for treating sinusitis |
US11116993B2 (en) * | 2016-06-17 | 2021-09-14 | Braxx Biotech Co., Ltd | Catheter apparatus and brachytherapy system |
US11364370B2 (en) | 2010-09-23 | 2022-06-21 | Best Medical International, Inc. | Multi-purpose balloon catheter for intra cavity radiation delivery |
US11446515B2 (en) | 2014-04-02 | 2022-09-20 | Ancer Medical, Inc. | Internal body cavity therapeutic applicators and methods for using them |
US11511087B2 (en) * | 2010-09-23 | 2022-11-29 | Best Medical International, Inc. | Dual double balloon catheter |
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EP0778051B1 (en) | 1995-12-05 | 2003-04-09 | Schneider (Europe) GmbH | Filament for irradiating a living body and method for producing a filament for irradiating a living body |
US5855546A (en) | 1996-02-29 | 1999-01-05 | Sci-Med Life Systems | Perfusion balloon and radioactive wire delivery system |
US6676590B1 (en) | 1997-03-06 | 2004-01-13 | Scimed Life Systems, Inc. | Catheter system having tubular radiation source |
US6019718A (en) | 1997-05-30 | 2000-02-01 | Scimed Life Systems, Inc. | Apparatus for intravascular radioactive treatment |
ATE227145T1 (en) | 1997-09-26 | 2002-11-15 | Schneider Europ Gmbh | BALLOON CATHETER INFLATED WITH CARBON DIOXIDE FOR RADIOTHERAPY |
US6264596B1 (en) | 1997-11-03 | 2001-07-24 | Meadox Medicals, Inc. | In-situ radioactive medical device |
US6352501B1 (en) | 1999-09-23 | 2002-03-05 | Scimed Life Systems, Inc. | Adjustable radiation source |
US6302865B1 (en) | 2000-03-13 | 2001-10-16 | Scimed Life Systems, Inc. | Intravascular guidewire with perfusion lumen |
JP4538918B2 (en) | 2000-08-02 | 2010-09-08 | 株式会社カネカ | Medical catheter for treating part of a body tube with ionizing radiation |
DE102004008373B3 (en) | 2004-02-20 | 2005-09-29 | Siemens Ag | Apparatus for performing and monitoring endovascular brachytherapy |
DE102004008366B3 (en) * | 2004-02-20 | 2005-09-15 | Siemens Ag | Apparatus for performing laser angioplasty with OCT monitoring |
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Also Published As
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CA2242996A1 (en) | 1999-03-26 |
DE59708672D1 (en) | 2002-12-12 |
JPH11114077A (en) | 1999-04-27 |
JP2001112876A (en) | 2001-04-24 |
ATE227145T1 (en) | 2002-11-15 |
EP0904798B1 (en) | 2002-11-06 |
CA2242996C (en) | 2007-11-13 |
AU7183598A (en) | 1999-04-15 |
EP0904798A1 (en) | 1999-03-31 |
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